Clinical Research Specialist II Job at University of Rochester (Rochester)

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Site Specialist II

We are currently seeking a Site Specialist II to join our diverse and dynamic te...

Location

China , Shanghai

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 3 years of experience as a SSU
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment

Job Responsibility

Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
Collaborating with investigators and site staff to facilitate smooth study conduct
Performing data review and resolution of queries to maintain high-quality clinical data
Contributing to the preparation and review of study documentation, including protocols and clinical study reports

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

Clinical Research Specialist II

We are seeking a time-as-reported (10 – 15 hours), bilingual (American Sign Lang...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Master's degree in psychology, social work, counseling, or related mental health field required
1 year of experience in clinical work or an equivalent combination of education and experience in clinical work with Deaf individuals required
Fluent in American Sign Language (ASL) and capable of adapting to the language needs of diverse Deaf individuals required
Experience working with the Deaf community required
Must maintain eligibility to participate in research involving human subjects by completing the Human Subjects Protection Program (HSPP) and NIH’s Good Clinical Practice training
Participation in available cultural competency training required

Job Responsibility

Conduct Deaf CBT-TS intervention sessions with Deaf participants
Coordinate scheduling of intervention sessions
Manage the study email account
Utilize interpersonal skills, clinical knowledge, and clinical judgment to develop and maintain rapport
Utilize advanced Deaf cultural knowledge, ASL skills, and clinical judgment to effectively convey necessary information
Follow up with participants via email
Apply advanced clinical reasoning to provide appropriate support
Maintain security of study data
Present participation information at weekly meetings
Complete the Deaf CBT-TS training protocol

Parttime

Clinical Laboratory QC Specialist

The Clinical Laboratory Quality Control (QC) Specialist I performs and functions...

Location

United States , Madison

Salary:

76000.00 - 125000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemical, biological, or clinical laboratory sciences or medical technology from an accredited institution
For a degree not one of those listed above: 90 semester hours which must include 16 semester hours in chemistry (6 of which must be in inorganic chemistry)
16 semester hours in biology courses and 3 semester hours of math
2+ years of experience in a laboratory setting
1+ years of experience performing, reviewing and understanding quality control on a routine basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Authorization to work in the United States without sponsorship

Job Responsibility

All assigned job duties are performed following laboratory policies and procedures
Responsible for running daily QC scripts using statistical software and reviewing generated daily QC data
Responsible for identifying quality control issues, errors, and trends and promptly informing QC Specialist II and/or other QC team members of issues identified
May be requested to assist QC Specialist II and/or other QC team members in investigation of quality control issues, errors, and trends
May be requested to assist QC Specialist II and/or other QC team members in preparation of monthly quality control reports
Responsible for performing validations, verifications, and studies under the guidance of the QC Specialist II and/or other QC team members
Responsible for obtaining validation, verification, and study data for review
May be requested to assist in review of validation, verification, and study data
Assists QC Supervisor, QC Lead, and other QC team members in ensuring that all section turn-around times are maintained
Assists the QC Supervisor, QC Lead, and other QC team members by escalating concerns and answering technical questions from laboratory staff and others in Exact Sciences labs, as appropriate

What we offer

paid time off (including days for vacation, holidays, volunteering, and personal time)
paid leave for parents and caregivers
a retirement savings plan
wellness support
health benefits including medical, prescription drug, dental, and vision coverage
bonus eligible

Fulltime

Human subject research specialist ii

The Human Subject Research Specialist II will work across teams to 1) coordinate...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 2 years of experience in human subject coordination
Familiarity and comfort with Excel, ACESS, REDCap, and other databases
Transportation of biological samples to URMC labs
Community-facing experience, including communication with community stakeholders
Prior experience or comfort translating scientific concepts to general audiences
Prior experience with research studies conducting MRI and Phlebotomy assessments
Applicants must be trained, or willing to be trained to perform phlebotomy and assist with MRI scans
Strong written and verbal communication skills, especially with regard to interfacing with participants, individuals seeking services, community partners, and medical professionals
Prior training or interest in data management and/or statistics
Clean background check, valid driver’s license and reliable transportation

Job Responsibility

Coordinate a multi-tier perinatal health intervention program
Work on research studies at Mt. Hope Family Center to collect physiological and biological research data
Conduct research with families from diverse backgrounds
May include community-facing efforts
Occasional evenings and weekends required to accommodate participant’s schedules
Assists in implementing a universal perinatal prevention program
Conducts visit to ensure research participant adherence with protocol requirements, completes MRI and phlebotomy research assessments
Assists with documenting adverse events and reports to senior study staff, PI, Institutional Review Board (IRB), and/or any other required recipients or entities
Ensures all data are collected and secured within approved parameters and procedures
Includes providing transportation for subjects to attend research visits

Fulltime

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Demonstrated clinical research experience
Demonstrated start up experience
Demonstrated project management experience
Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
Concurrent management of complex processes within and across countries in multiple regions of the world
Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
Expert ability to comprehend status and adapt communications across a diverse audience
Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
Will use generative artificial intelligence techniques in daily work
Uses risk management techniques as standard to identify and mitigate key project delivery risks

Job Responsibility

Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies

Project Specialist

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

Taiwan , Taipei

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Good verbal and written communication skills
Developed interpersonal skills and ability to build relationships
Attention to detail and quality of work
Client focused approach to work
Flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm
Ability to prioritize workload
A willingness to work in a matrix environment and to value the importance of teamwork
Basic problem- solving ability
Professional interpersonal, verbal and written communication skills

Job Responsibility

Leading cross-functional teams to deliver high-quality and patient-focused clinical trials
Collaborating with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets
Core services provided by Project Specialist I and Project Specialist II include but are not limited to: Project Management Plans initial set up and maintenance with Project Leader input
Maintenance of selected information in the integrated project management system
Project reports, compliance and other metrics for project operational review, client and internal reporting and project oversight
Initial Review of selected financial areas
Cooperation with Project Leader and Functional Leads on action plans and follow up with the project team on action items
Oversight of project team list, project system accesses and respective reviews
Updating and customizing of systems and tools and project plans according to applicable SOPs
Supporting vendor selection

What we offer

Supportive work environment
High degree of empowerment and accountability
Flexible work arrangements (remote, in-office and hybrid roles)

Fulltime

Audiology Specialist II

Performs testing and examination using advanced audiology knowledge to determine...

Location

United States , Modesto

Salary:

Not provided

Kaiser Permanente

Expiration Date

Until further notice

Requirements

Minimum one (1) year of experience in a leadership role with or without direct reports
Doctorate degree in Audiology, Speech and Hearing Science, Communication Disorders AND minimum two (2) years of experience in audiology or a directly related field OR Masters degree in Audiology, Speech and Hearing Science, Communication Disorders AND minimum four (4) years of experience in audiology or a directly related field
Audiologist License (California) required at hire OR Temporary Audiologist License (California) required at hire
Audiologist License (California) within 12 months of hire
Basic Life Support required at hire
National Provider Identifier required at hire

Job Responsibility

Performs testing and examination using advanced audiology knowledge to determine a patients hearing level, balance assessment, and/or the site and nature of any damage
Interprets diagnostic audiological results with other diagnostic data to formulate the patients diagnosis, and plans several interrelated auditory disorder treatments
Conducts treatment for patients using advanced knowledge including habilitative, rehabilitative, or conservation programs, custom fitting, programming, and troubleshooting of hearing aids, and counseling individuals with auditory and balance disorders, their families, and other service providers
Maintains records of diagnostic findings and progress made utilizing appropriate software while providing input to other professionals
Independently conducts and evaluates clinical and research procedures as well as improved methods of evaluation of persons with auditory and balance disorders
Provides audiology education for patients and other professionals relating to pre-hearing aid expectations, post-purchase use and care, and hearing and balance disorders

Fulltime

Select Country

Clinical Research Specialist II

University of Rochester

Location:
United States of America , Rochester

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 21, 2026

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